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The epidemic of opioid abuse and the overdoses and deaths accompanying this public health scourge claimed even more victims in Berks County and beyond in 2016 than in 2015. On November 2, Governor Tom Wolf signed into law a package of bills requiring changes in the way health care practitioners prescribe opioid medications and putting the licensure of any practitioner who does not comply at risk. The new requirements include checking the PDMP system before writing every prescription for an opioid (or benzodiazepine), with some exceptions, and quantity limits on such prescriptions under certain circumstances.

A premise behind some of the new requirements is that one factor stoking the opioid epidemic has been careless prescribing habits by physicians and others, which need to be reined in. While there is some truth to this scenario, it is a gross over-simplification of the wider problem. Prescribing habits are just one small piece of a much larger puzzle. Raising barriers to the dispensing of prescriptions for opioids is likely to make it more difficult for some pain sufferers to obtain relief and will do little to put the brakes on the opioid epidemic unless more action is taken to address the other pieces of the puzzle, which include barriers to the access of alternative pain management treatments, lack of access to addiction treatment, and the easy availability of inexpensive heroin.

A brief summary of the bills which affect opioid prescribing appears next, followed by comments from Berks County Medical Society members.

— Lucy J. Cairns, M.D., Editor

Summary of Recent Pennsylvania Opioid Legislation

HB 1699, sponsored by Representative Rosemary M. Brown, will limit the prescribing of an opioid drug product to an individual seeking treatment in certain settings (an emergency department (ED) or urgent care center, or an individual who is in observation status in a hospital), to no more than a quantity sufficient to treat that individual for up to seven days. HB 1699 does contain an exception that allows a health care practitioner to prescribe more than a seven-day supply to treat a patient’s acute medical condition or if it is deemed necessary for the treatment of pain associated with a cancer diagnosis or for palliative care. In order to go beyond the seven-day limit, a health care practitioner must document in the individual’s medical record that a non-opioid alternative was not appropriate to treat the medical condition. Regardless of the amount prescribed, a health care practitioner under these settings is prohibited from writing a prescription that allows for a refill for an opioid drug product.

Other parts of the bill require:

A health care practitioner under these settings to refer an individual for treatment if the individual is believed to be at risk for substance abuse while seeking treatment.

A health care practitioner under these settings to query the Prescription Drug Monitoring Program (PDMP) system to determine whether a patient may be under treatment with an opioid drug product by another health care practitioner. This requirement does not apply to any medication provided to a patient in the course of treatment while undergoing care in an ED.

Health care practitioners who violate the provisions of this bill are subject to licensure sanctions by the appropriate state board, although practitioners who comply with the provisions of this bill are presumed to be acting in good faith and will have immunity from civil liability.

SB 1202 – Revisions to the PDMP law

SB 1202, sponsored by Senator Gene Yaw, will amend the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) law, better known as the PDMP law. SB 1202 contains several major revisions to the PDMP law, including:

Requiring dispensers to query the PDMP system before dispensing an opioid drug product or a benzodiazepine prescribed to a patient under certain circumstances.

Requiring prescribers to query the PDMP system each time a patient is prescribed an opioid drug product or a benzodiazepine. However, querying is not required if a patient has been admitted to a licensed health care facility or is in observation status in a licensed health care facility after the initial query as long as the patient remains admitted to the licensed health care facility or remains in observation status in a licensed health care facility.

Requiring an individual applying for an initial license or certification issued by a licensing board to be a dispenser or prescriber, to complete, within the first 12 months after obtaining the initial license or certification, four hours of education, with those hours being at least two hours of education in pain management or identification of addiction and at least two hours of education in the practices of prescribing or dispensing of opioids.

Requiring dispensers or prescribers applying for the renewal of a license or certification to complete at least two hours of continuing education in pain management, identification of addiction or the practices of prescribing or dispensing of opioids.

The education indicated above is not in addition to the 100-hour CME requirement for physicians but rather is part of the 100-hour CME requirement. In addition, prescribers who don’t have their own DEA number and who do not use the registration number of another person or entity as permitted by law to prescribe controlled substances are exempt from this CME requirement.

SB 1367 – Opioid prescribing for minors

SB 1367, sponsored by Senator Gene Yaw, will limit the amount of opioids that may be prescribed to a minor to no more than a seven-day supply unless a prescriber determines that more than a seven-day supply is needed to stabilize the minor’s acute medical condition. For the exception to apply, the prescriber is required to document the acute medical condition in the minor’s record with the prescriber; indicate the reasons why a non-opioid alternative is not appropriate to address the minor’s acute medical condition; and that the prescription is for management of pain associated with cancer, for use in palliative or hospice care, or for management of chronic pain not associated with cancer.

Before prescribing an opioid for the first time to a minor, a prescriber is required to do the following:

Assess whether the minor has taken or is currently taking prescription drugs for treatment of a substance use disorder.

Discuss with the minor and the minor’s parent, guardian, or with an authorized adult certain specified risks and dangers.

SB 1367 will require the Department of State’s Bureau of Professional and Occupational Affairs, in consultation with the licensing boards, to create a standardized form for prescribers to use to obtain written consent from a minor’s parent, guardian, or authorized adult, in order to prescribe an opioid to that minor.
Violations of this bill may subject a prescriber to administrative sanctions by the appropriate licensing board.

SB 1368 – Opioid Education and voluntary non-opioid directive

SB 1368, sponsored by Senator Thomas H. Killion, will require the licensing boards to implement curriculum regarding safe prescribing practices for controlled substances containing opioids. This curriculum may be offered by medical schools, medical training facilities, dental schools, and other providers. This education will not be mandated as a graduation requirement but will instead be left up to each educational institution to determine whether it will be required for graduation.
SB 1368 will also allow a patient to sign a form prohibiting the prescribing or administering of a controlled substance containing an opioid to that patient. Guidelines for the implementation of this form will be drafted by the Department of Health.

Practitioner who recklessly or negligently fail to comply with a patient’s voluntary non-opioid directive may be subject to a licensure sanction by the applicable state board.

The heroin and opioid epidemic is sweeping the nation and unfortunately Pennsylvania and Berks County have not been immune to this terrible problem. While I applaud our state legislators’ efforts to curb this epidemic, passing legislation limiting the ability of Emergency Medicine physicians to prescribe pain medication creates a slippery slope with respect to the practice of medicine. Although it is unusual for an Emergency Medicine physician to prescribe more than seven days of medication, there are circumstances that would necessitate longer prescriptions.

Emergency Physicians are very conscious of this issue and in 2014 the Pennsylvania College of Emergency Physicians passed a guideline for the treatment of pain in the Emergency Department. Until exceptions are clearly defined, HB 1699 has the potential to place physicians and patients in a difficult situation both medically and legally. Some areas of the Commonwealth continue to struggle with access to care issues and there are times that patients have significant, acute pain and are not able to schedule an appointment with a specialist or their primary care physician within a reasonable period of time. In these circumstances, the Emergency Department remains the safety net for this population of patients. I am encouraged by the efforts of our State Representatives to eradicate this epidemic of opioid abuse and hopeful that the Pennsylvania Medical Society can work hand in hand with the legislature to amend this legislation to ensure that appropriate patient care pain needs are addressed.

Jason T. Bundy, M.D.Center for Pain Control

I read the summarized bills with great interest. My response is perhaps like that of many physicians: “Oh great, more legislative mandates, more red tape, more liability and less physician autonomy.” Certainly the PDMP and better education / awareness about the prescription opioid abuse epidemic are all steps in the right direction. However, it seems excessive to hold Pennsylvania physicians medico-legally liable for not accessing (or paying a proxy to access) the PDMP every single time a legitimate, low-risk chronic pain patient with consistent drug screens receives a controlled substance prescription. In addition, the state legislature seems to have fallen into a pattern of withholding medical licensure over very specific medical training issues like child abuse recognition and now opioid prescribing. Shouldn’t physician training programs be teaching this material from day one? If they aren’t, maybe their federal funding should be withheld instead of piling on more unfunded physician mandates.

Anyway, I predict that if Governor Wolf signs this legislation into law, it will indeed make it harder for all patients in the state to remain on controlled substance pain medications. That is probably a good thing for patients struggling with addiction issues, but definitely a bad thing for chronic pain patients that are earnestly struggling with severe pain and have few other options. These chronic pain patients may not be able to find a physician willing to prescribe controlled substance pain medications because the liability and / or hassle of prescribing them have simply grown too burdensome. (I am already seeing that trend here in Berks County due to the recently released CDC opioid prescribing guidelines for primary care physicians.) I predict that this type of legislation will only accelerate this problematic trend because there simply aren’t enough chronic pain management physicians available in this state to care for all the patients who have a legitimate need for ongoing opioid treatment.

Jo Kelly, M.D.Pediatric MedicineReading Pediatrics

SB 1367 provides a new awareness for both prescribers and patients about the dangers of opioid medications especially for minors. It is good for patients and their parents to be educated about the addiction potential. These conversations might take a little more time for prescribers but the prevention of addiction and the hardship it causes for many families in our society will make it more than worth it! Many families are unaware that the longer opioid medications are taken the more potential there is for addiction. Some patients also don’t try a lesser pain medication because “the strong one is working.” They may be afraid that they will not have adequate treatment of their pain. The seven-day limit will at least require a patient to take a non-opioid at that point and see if it is sufficient in controlling their pain. In many instances it will be. If it is not, then more conversations and reevaluations can occur, allowing a plan to be devised to make sure the medications are not overused.

The law allows for exceptions such as pain from cancer, use in palliative care and for the management of chronic pain not caused by cancer. These exceptions must be well documented. The law also asks that prescribers assess whether a minor has been treated for a substance abuse disorder and is taking or has taken medications to treat a substance abuse disorder. This is protective for both patients and prescribers. The consents take a little more time to explain and require more paperwork, but given the epidemic of addiction in our society, these conversations are crucial and necessary to make sure everyone involved understands the risks and dangers of opioid medications.

Anne P. Ambarian, M.D. Family MedicinePatient First Urgent Care

As with most requirements and regulations in our profession, they are usually a direct result of things gone awry. The opioid prescribing laws are no different. Briefly, providers are now required to do CME on opioid prescribing, query the Prescription Drug Monitoring Program (PDMP) every time an opioid or benzodiazepine is written, and be aware of consent and quantity limits for minors. In addition, Emergency Departments and Urgent Care Centers are restricted to a quantity of treating for no more than 7 days.

The PDMP is fairly user friendly but obviously is one more step and takes more time. The biggest complaints were the initial annoyance of the PDMP program being easily accessible on all computers and remembering yet another password that changes. The other rules are basically common sense. A minor should have consent to get these medications, and now we will have the added step of being required to obtain written consent. Most emergency departments and urgent care centers are not giving out 7 days of these substances even without the law, so in essence, no change for us.

There certainly are positives, including objective data about patients’ prescriptions including date prescribed and quantity given, deterring duplicate and over-prescribing (we in Urgent Care hope for an “antibiotic” PDMP). It has opened up communication about the addictive and harmful effects of misuse and overuse. I have personally seen several patients who have been weaned off chronic narcotics and feel much better. All of which is great news! Overall, the program is more positive than negative.

Lee Radosh, MDDirector, Family Medicine ResidencyReading Hospital

Finally, the “opioid crisis” is getting attention. This affects (kills!) so many more people than so many other illnesses/infections to which we devote much greater resources. We have routinely asked patients about trips to Africa, and spend exorbitant time and money preparing for potential infectious epidemics. Yet people die in mass numbers – daily – right in front of us, and we do virtually nothing. Until now.
While I loathe laws and government interventions dictating how I practice medicine, I can understand the rationale for political intervention. This is a public health crisis. It drains our state and federal finances, and well-intentioned leaders want to do something.

It is reasonable to expect practitioners to check databases, and exercise due diligence when prescribing these potentially dangerous therapeutics. However, until there are automated pathways, unfunded government mandates may be counterproductive.

Some reflections based on my experiences:

Unforeseen consequences . . . With so much pressure to avoid these medications, and heavy burdens for those who do prescribe, more and more clinicians are simply saying no, they won’t manage these medications. This means the few providers left will be overwhelmed, patients will be even more viewed as pariahs as they move in desperation among clinicians, and many will turn to the cheaper, more accessible heroin. The term “opioid refugee” is becoming more commonplace describing this situation.

Much has been written regarding the perfect storm of factors that got us where we are. But this is also a symptom of global issues such as lack of access to – and affordability of – mental health treatment, addiction services, and pain management. No legislation to limit opioids will achieve its goals without addressing these barriers.

Those of us in primary care must admit sad truths, through no fault of our own. It is quicker and easier to prescribe a month of opiates than dig deep into root causes of a patient’s complaint. Why waste time referring to physical therapy when many patients – even with insurance – can’t afford co-pays, certainly can’t afford the time off to go? The most complex patients often do not follow-up with referrals to psychiatry and other specialists. The wait times can themselves be prohibitive, and sometimes the patient then gets kicked out of that practice. They invariably land back in the PCP’s lap, to send to the overburdened emergency department, or dismiss from the practice to become someone else’s problem. But we often continue to sub-optimally manage, as the limited alternatives available to patients may be worse, and we want to help. And imagine what the effect will be when more PCP compensation is tied to patient satisfaction! The bottom line: until we fundamentally change how primary care is compensated, these patients wander and suffer. Society cannot expect great care of these patients in a 15 minute office visit, and the current reimbursement structure for primary care makes (the necessary) longer office visits financially nonviable.

We are fortunate to have some excellent pain management experts locally who truly provide comprehensive care. Unfortunately, many others provide injections but then send the patient back to the PCP when the injection wears off. And the cycle continues.

Many guidelines for pain management have been established, most of which are perfect for “la-la land.” You, a reader of this journal, are an affluent member of society. Yet even you might recoil from the costs (financial, and especially time off from work and other responsibilities) for recommended therapies usually not covered by insurance: massage therapy, acupuncture, yoga, and other non-pharmacologic interventions. Now, imagine you are a blue-collar worker already struggling to make ends meet. Helpful guidelines? For many patients, I think not.

There is of course overlap among patients with chronic pain, those on chronic opioids, those addicted, and those suffering from co-morbid mental health conditions. However, we must remember that too often these terms and categories are used interchangeably. Each patient is different. Each issue deserves its own attention for reform.

For those addicted, in addition to counseling and many other traditional treatments, there are now effective, proven medications to assist with abstinence. Embarrassingly, most physicians are probably more comfortable diagnosing lupus and writing for hydroxychloroquine, than diagnosing opiate-use disorder and writing for medication-assisted treatment such as a naltrexone formulation (such as long-acting Vivitrol).

These are some of the barriers in combatting this epidemic. There are innovative signs of progress; the warm hand-off program in the Reading Hospital Emergency Department is one example. But in early December, the Philadelphia news reported 35 heroin overdoses in a 5-day span. Imagine if the headline read “35 deaths in 5 days from new virus X.” People would wear masks on the subway in fear, and there would be emergency legislative sessions! We must let our policies and medical practice be dictated by the data of what really affects patients. But without addressing the previously described issues, well-intentioned recent laws will probably only scratch the surface.

I don’t know any physician that doesn’t struggle with the work-life balance. We didn’t become physicians because we expected an easy job. And most of us understand that to be truly good at anything, it probably takes some talent, but it definitely requires a lot of work. There is no substitute for investing your time, from studying in medical school, working and studying in residency and fellowship, and working while continuing the learning process as an attending physician. But it doesn’t stop there.

Background

Relief of cancer pain from opioids is rarely all or nothing; most patients experience some degree of analgesia alongside opioid toxicities. When the balance of analgesia versus toxicity tips away from analgesia, the term ‘opioid poorly-responsive pain’ is invoked. While opioid poorly-responsive pain is not a discreet syndrome, it is a commonly encountered clinical scenario. This Fast Fact reviews key points in its assessment and management.

Differential Diagnosis of Opioid Poorly-Responsive Pain

Cancer-related pain

Cancer progression (new fracture at site of known bone metastases).

Causes of pain (eg. neuropathic pain, skin ulceration, rectal tenesmus, muscle pain) that are known to be less responsive to systemic opioids or opioid monotherapy.

Complete a physical examination and order diagnostic studies as indicated.

Escalate a single opioid until acceptable analgesia or unacceptable toxicity develop, or it is clear that additional analgesic benefit is not being derived from dose escalation. If this fails, consider:
i. Rotating to a different opioid (e.g. morphine to methadone).
ii. Changing the route of administration (e.g. oral to subcutaneous).

Version History: Originally published May 2009; copy-edited August 2015.

Fast Facts and Concepts are edited by Sean Marks, MD (Medical College of Wisconsin) and associate editor Drew A Rosielle, MD (University of Minnesota Medical School), with the generous support of a volunteer peer-review editorial board, and are made is available online by the Palliative Care Network of Wisconsin (PCNOW); the authors of each individual Fast Fact are solely responsible for that Fast Fact’s content. The full set of Fast Facts are available at Palliative Care Network of Wisconsin with contact information, and how to reference Fast Facts.

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